Device recall enforcement reports

MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201

Nipro Renal Soultions USA, Corporation · Hemodialysis concentrates contain high endotoxin levels

Class IIOngoingZ-3133-2026
Status
Ongoing
City
Lewisberry
State
PA
Country
United States
Classification
Class II
Product type
Devices
Event ID
99573
Recalling firm
Nipro Renal Soultions USA, Corporation
Address 1
509 Fishing Creek Rd
Postal code
17339-9517
Voluntary mandated
Voluntary: Firm initiated
Initial firm notification
Letter
Distribution pattern
Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama.
Recall number
Z-3133-2026
Product description
MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
Product quantity
3,286 cases
Reason for recall
Hemodialysis concentrates contain high endotoxin levels
Recall initiation date
20260805
Center classification date
20260910
Report date
20260916
Code info
BC-100 - Lot:N4L022 (exp.11/13/2026), N4L037(exp.11/18/2026) BC+201- Lot: N4L010(exp.11/06/2026)
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.